A Study of JNJ-90189892 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Neoplasms
Recruiting now · Phase 1
Conditions studied: Leukemia, Myeloid, Acute, Myelodysplastic Neoplasms
In brief
The purpose of Part 1 (Dose Escalation) of the study is to assess the effective dose (recommended Phase 2 dose\[s\] \[RP2Ds\]) that can be safely administered, and dosing regimens of JNJ-90189892 in participants with relapsed or refractory (R/R) acute myeloid leukemia (AML) or R/R higher-risk type of myelodysplastic neoplasms (MDS \[type of cancer of the blood and bone marrow, which does not respond to treatment or comes back after treatment\]). The purpose of Part 2 (Cohort Expansion) is to further assess the safety, tolerability and efficacy in participants with R/R AML or higher-risk types of MDS at the RP2D regimen(s). The purpose of Part 3 and 4 is to assess the effective dose (recommended Phase 2 combination dose \[RP2CD\]) that can be safely administered, and dosing regimens of JNJ-90189892 in combination with azacitadine (AZA) + venetoclax (VEN) in participants with R/R AML (part 3) and newly diagnosed (ND) AML (part 4).
Key facts
- Study ID
- NCT06651229
- Run by
- Janssen Research & Development, LLC
- People needed
- 155
- Starts
- 2025-03-21
- Expected to finish
- 2028-11-21
- Last updated by the study team
- 2026-07-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- A. For Parts 1, 2, and 3: Have a diagnosis, per the world health organization (WHO) 2022 criteria, of (a) Parts 1, 2, and 3: Acute myeloid leukemia (AML) or (b) Parts 1 and 2: Moderate high, high, or very high-risk myelodysplastic neoplasms (MDS) per Molecular International Prognostic Scoring System (IPSS-M); B. For Part 4 only: Previously untreated acute myeloid leukemia (AML) per the WHO 2022 criteria
- Body weight that is greater than or equals to (>=) 40 kg
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Have adequate renal function defined as Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Estimated Glomerular Filtration Rate (eGFR) >=40 milligrams per minute (mL/min) computed with the calculator on the national kidney foundation website
- Participants must have laboratory parameters in the required range
You may not qualify if…
- Has a medical history of clinically significant pulmonary compromise, particularly the current need for supplemental oxygen use to maintain adequate oxygenation
- Has evidence of uncontrolled systemic viral, bacterial, or fungal infection. Antimicrobial prophylaxis is permitted
- All participants- Has known allergies, hypersensitivity, or intolerance to JNJ-90189892 or its excipients; Parts 3 and 4- Has known allergies, hypersensitivity, or intolerance to venetoclax (VEN), azacitadine (AZA), or their excipients
- Had major surgery or had significant traumatic injury within 14 days of planned first dose of JNJ-90189892
- Had a prior or concurrent second malignancy with natural history or treatment likely to interfere with any study endpoints of safety or the efficacy of the study treatment
- Has known active central nervous system involvement
Where it is running
- Concord Hospital — Concord, Australia (enrolling)
- Peter MacCallum Cancer Centre — Melbourne, Australia (enrolling)
- Sir Charles Gairdner Hospital — Nedlands, Australia (enrolling)
- Institut Paoli-Calmettes — Marseille, France (enrolling)
- CHRU de Strasbourg - Hopital de Hautepierre — Strasbourg, France (enrolling)
- Institut Claudius Regaud — Toulouse, France (enrolling)
- Hosp Univ Fund Jimenez Diaz — Madrid, Spain (enrolling)
- Clinica Univ. de Navarra — Pamplona, Spain (enrolling)
- Hospital Universitario Virgen Rocio — Seville, Spain (enrolling)
Full record on ClinicalTrials.gov
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